—#147801

Product

Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K023264
Affected lot / code info: Software version 9.15

Why it was recalled

A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.

Root cause (FDA determination)

Software design

Action the firm took

The firm, BD, sent an "Urgent: Medical Device Recall Notification" letter dated 8/8/16 to customers to inform them that BD has identified a software anomaly associated with the Alaris Syringe module software version 9.15. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the instructions and promptly complete and return the Customer Response Card to expedite the corrective action process. Customers with recall related questions are instructed to contact the BD Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.

Timeline

Recall initiated: 2016-08-08
Terminated: 2018-10-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.